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A large-scale nationwide multicenter prospective observational study of triple therapy using rabeprazole, amoxicillin, and clarithromycin for Helicobacter pylori eradication in Japan

  • Original Article—Alimentary Tract
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Abstract

Background

In recent years in Japan, the rate of clarithromycin (CAM) resistance in Helicobacter pylori has risen to around 30%, and the eradication rate with triple therapy [proton pump inhibitor + amoxicillin (AMPC) + CAM] has been trending downward to around 70%. In 2007, rabeprazole (RPZ)-based triple therapy (RPZ + AMPC + CAM: RAC therapy) was approved in Japan, and a large-scale nationwide study was therefore initiated to evaluate the efficacy and safety of RAC therapy in clinical practice.

Methods

Patients with H. pylori-positive gastric/duodenal ulcer (including ulcer scars) were administered triple therapy comprising RPZ 10 mg, AMPC 750 mg, and CAM 200 mg (or 400 mg), twice daily for 7 days.

Results

The eradication rate was 80.7% (2,551/3,162). The results of multivariate analysis indicated the following as factors affecting the eradication rate: sex, treatment compliance, history of H. pylori treatment, presence of urologic disease, presence of respiratory disease, and year of starting treatment. The incidence of adverse drug reactions (such as diarrhea and dysgeusia) was 4.4% (166/3,789). The results of multivariate analysis indicated the following as factors affecting the incidence of adverse drug reactions: sex, daily CAM dose, and history of allergies.

Conclusion

In a large-scale nationwide study of use in clinical practice, RAC therapy was confirmed to be effective and safe.

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Acknowledgments

This study was conducted by Eisai Co., Ltd., based on instructions from the Ministry of Health, Labour and Welfare of Japan at the time of RAC therapy approval. We would like to express our sincere gratitude to all the investigators and sub-investigators at the 754 facilities nationwide who cooperated with this study and provided crucial data. Toshio Fujioka, M.D., Ph.D., serves as a consultant to Eisai Co., Ltd.

Conflict of interest

None.

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Authors and Affiliations

  1. Department of Gastroenterology, Faculty of Medicine, Oita University, 1-1 Idaigaoka, Hasama-machi, Yufu, Oita, 879-5593, Japan

    Toshio Fujioka

  2. GI Endoscopy and IBD Center, Aoyama Clinic, Kobe, Japan

    Nobuo Aoyama

  3. Center for Digestive and Liver Diseases, Nara City Hospital, Nara, Japan

    Kyoko Sakai

  4. Miwa Clinic, Gifu, Japan

    Yoshiyuki Miwa

  5. Department of Gastroenterology, Sapporo Hokuyu Hospital, Sapporo, Japan

    Mineo Kudo

  6. Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama, Japan

    Junichi Kawashima & Koji Yakabi

  7. Department of Gastroenterology, Toshiba General Hospital, Tokyo, Japan

    Yasuo Matsubara & Jun Miwa

Authors
  1. Toshio Fujioka
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  2. Nobuo Aoyama
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  3. Kyoko Sakai
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  4. Yoshiyuki Miwa
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  5. Mineo Kudo
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  6. Junichi Kawashima
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  7. Yasuo Matsubara
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  8. Jun Miwa
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  9. Koji Yakabi
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Correspondence to Toshio Fujioka.

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Fujioka, T., Aoyama, N., Sakai, K. et al. A large-scale nationwide multicenter prospective observational study of triple therapy using rabeprazole, amoxicillin, and clarithromycin for Helicobacter pylori eradication in Japan. J Gastroenterol 47, 276–283 (2012). https://doi.org/10.1007/s00535-011-0487-6

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  • DOI: https://doi.org/10.1007/s00535-011-0487-6

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